THE HAYEK OSCILLATOR
Device Facts
| Record ID | K903745 |
|---|---|
| Device Name | THE HAYEK OSCILLATOR |
| Applicant | Flexco Medical Instruments |
| Product Code | BYT · Anesthesiology |
| Decision Date | Nov 9, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5935 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.
